MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT

Model Number OPT94X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint opt94x interfaces have been discarded by the hospital and are not available to be returned to fisher & paykel healthcare in (b)(4) for evaluation, and no lot information was provided.We are currently in the process of gathering further information from the hospital regarding this complaint.We will provide a follow-up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare field representative that they had patients who experienced pressure sores while using the opt94x series nasal cannula (sizes unknown).It was further reported that one patient had a grade 3 pressure sore on the top of their ear.The hospital stated that the patient with the grade 3 pressure sore improved and was discharged from the ward.No further patient consequences were reported.

Event Description

A hospital in the uk reported via a fisher & paykel healthcare field representative that they had patients who experienced pressure sores while using the opt94x series nasal cannula (sizes unknown).It was further reported that one patient had a grade 3 pressure sore on the top of their ear.The hospital stated that the patient with the grade 3 pressure sore improved and was discharged from the ward.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).The opt944 interface is used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint opt94x interface was discarded by the hospital and not available to be returned to fisher & paykel healthcare in new zealand for evaluation.Therefore, our investigation was performed based on the information provided by the customer and our knowledge of the product.Conclusion: we were unable to confirm what caused the pressure sore on the patient's ear.However, based on our knowledge of the product, pressure sores are often a result of incorrect set up.Upon receiving this complaint, the local fisher & paykel healthcare field representative organized further training to the customer highlighting correct positioning of the interface strap around the crown of the head to avoid rubbing over the ears, and appropriate tightness for the patients' cheeks and nose.The user instructions which accompany the opt94x series nasal cannula contain pictorial instructions for setting up the nasal cannula.The instructions also state that the interface is intended to be used "for delivery of humidified respiratory gases" and includes the following cautions/warnings: - do not crush or stretch tube, to prevent loss of therapy.- failure to use the set-up described above can compromise performance and affect patient safety.

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8525498
• MDR Text Key: 142496078
• Report Number: 9611451-2019-00376
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT94X
• Device Catalogue Number: OPT94X
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1